Hyaluronic Acid in Acute Exacerbation of COPD - Duration Of Noninvasive Assistance (HAEC-DONA)

Campus Bio-Medico University of Rome

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: HMW-HA; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02674880

15.1(15PT).15 ComEt-CBM

ES102605 (Other Grant/Funding Number)

Details and patient eligibility

About

The objective of this study is to test the effect of High Molecular Weight Hyaluronic Acid (HMW-HA) on Non Invasive Ventilation (NIV) effectiveness in patients admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).

Full description

The objective of this study is to test the effect of HMW-HA on NIV effectiveness in patients admitted to a sub-intensive care unit for respiratory failure due to acute exacerbation of COPD. The design is a parallel-arm, single-blind, placebo-controlled randomized clinical trial. Eighty patients, aged eighteen years or older, admitted for respiratory failure primarily due to COPD exacerbation and requiring non-invasive ventilation will be enrolled and randomized to the study treatment (active or placebo).

All patients will be treated with NIV delivered using a Hamilton C1 ventilator and medical therapy according to current guidelines (inhaled long-acting b2 agonists, inhaled long-acting anticholinergic, inhaled and systemic corticosteroids, antibiotics). Patients randomized to the active intervention group will also receive HMW-HA (Yabro® - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer b.i.d., while patients randomized in the control group will receive a matching placebo. Patients will be treated until weaning or until NIV failure, defined as oro-tracheal intubation or death.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years of age or older
• Admitted for respiratory failure primarily due to COPD exacerbation
• Requiring non-invasive ventilation
• Respiratory distress, as evidenced by moderate-to-severe dyspnea and use of accessory muscles of respiration
• Hypercapnic respiratory failure
• High respiratory rate

Exclusion criteria

• Respiratory arrest or the need for immediate intubation
• Upper airways obstruction
• Facial trauma
• Inability to cooperate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups, including a placebo group

HMW-HA

Experimental group

Description:

HMW-HA (Yabro - 5 ml of saline containing 0.3% hyaluronic acid sodium salt) via nebulizer b.i.d.

Treatment:

Drug: HMW-HA

Placebo

Placebo Comparator group

Description:

5 ml of saline via nebulizer b.i.d.

Treatment:

Other: Placebo